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2001)
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY


OTSUKA PHARMACEUTICAL CO., LTD.,

Plaintiff,

v.

SUN PHARMACEUTICAL INDUSTRIES
LTD., SUN PHARMA GLOBAL INC., SUN
PHARMA GLOBAL FZE, SUN PHARMA
USA and CARACO PHARMACEUTICAL
LABORATORIES, LTD.,
Defendants.
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Civil Action No.:

COMPLAINT FOR PATENT INFRINGEMENT
Plaintiff Otsuka Pharmaceutical Co., Ltd. (Otsuka), by way of Complaint against Sun
Pharmaceutical Industries Ltd. (Sun Ltd.), Sun Pharma Global Inc. (Sun Inc.), Sun Pharma
Global FZE, Sun Pharma USA (Sun USA) and Caraco Pharmaceutical Laboratories, Ltd.
(Caraco) (collectively, Defendants), alleges as follows:
THE PARTIES
1. Otsuka is a corporation organized and existing under the laws of Japan with its
corporate headquarters at 2-9 Kanda Tsukasa-machi, Chiyoda-ku, Tokyo, 101-8535, Japan.
Otsuka is engaged in the research, development, manufacture and sale of pharmaceutical
products.
2. Upon information and belief, Sun Ltd. is a corporation organized and existing
under the laws of India, having its principal place of business at Acme Plaza, Andheri - Kurla
Road, Andheri (E), Mumbai, 400 059, India.


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3. Upon information and belief, Sun Inc. is a corporation organized and existing
under the laws of the British Virgin Islands, and maintains a post office box at International
Trust Building, P.O. Box No. 659, Road Town, Tortola, British Virgin Islands. Upon
information and belief, Sun Inc. is a wholly-owned subsidiary of Sun Ltd.
4. Upon information and belief, Sun Pharma Global FZE is a corporation organized
and existing under the laws of the United Arab Emirates, having a principal place of business at
Office # 43, Block Y, SAIF-Zone (Sharjah Airport International Free Zone), Sharjah, United
Arab Emirates. Upon information and belief, Sun Pharma Global FZE is a wholly-owned
subsidiary of Sun Inc.
5. Upon information and belief, Sun USA is a wholly-owned subsidiary and the
United States arm of Sun Ltd., with its principal place of business at 1150 Elijah McCoy Drive,
Detroit, MI, 48202.
6. Upon information and belief, Caraco is a corporation organized and existing
under the laws of Michigan, having a facility at 270 Prospect Plains Rd., Cranbury, NJ 08512.
Upon information and belief, Caraco is a wholly-owned subsidiary of Sun USA. Upon
information and belief, Caraco is an authorized agent of Sun Pharma Global FZE. Upon
information and belief, Caraco may also be doing business as Sun Pharmaceutical Industries, Inc.
NATURE OF THE ACTION
7. This is an action for infringement of U.S. Patent No. 8,017,615 (the 615
patent), U.S. Patent No. 8,580,796 (the 796 patent) and U.S. Patent No. 8,642,760 (the 760
patent), arising under the United States patent laws, Title 35, United States Code, 100 et seq.,
including 35 U.S.C. 271 and 281. This action relates to Sun Pharma Global FZEs filing of
an Abbreviated New Drug Application (ANDA) under Section 505(j) of the Federal Food,


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Drug and Cosmetic Act (the Act), 21 U.S.C. 355(j), seeking U.S. Food and Drug
Administration (FDA) approval to manufacture, use, sell and offer to sell generic
pharmaceutical products (Sun Pharma Global FZEs generic products) before the expiration of
the asserted patents.
JURISDICTION AND VENUE
8. This Court has subject matter jurisdiction under 28 U.S.C. 1331 and 1338(a).
9. Upon information and belief, this Court has jurisdiction over Sun Ltd. Sun Ltd. is
in the business of manufacturing, marketing, importing and selling pharmaceutical drug
products, including generic drug products. Upon information and belief, Sun Ltd., directly or
through its wholly-owned subsidiaries, including Sun Inc., Sun Pharma Global FZE, Sun USA
and Caraco, manufactures, markets, imports and sells generic drugs throughout the United States
and in this judicial district. Sun Ltd. has previously submitted to the jurisdiction of this Court
and has further previously availed itself of this Court by asserting counterclaims in other civil
actions initiated in this jurisdiction.
10. Upon information and belief, this Court has jurisdiction over Sun Inc. Upon
information and belief, Sun Inc. is in the business of manufacturing, marketing, importing and
selling pharmaceutical drug products, including generic drug products. Upon information and
belief, Sun Inc., directly or through its parent, subsidiaries, affiliates and/or agents, including Sun
Ltd., Sun Pharma Global FZE, Sun USA and Caraco, manufactures, markets, imports and sells
generic drugs throughout the United States and in this judicial district. Sun Inc. has previously
submitted to the jurisdiction of this Court and has further previously availed itself of this Court
by asserting counterclaims in other civil actions initiated in this jurisdiction.


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11. Upon information and belief, this Court has jurisdiction over Sun Pharma Global
FZE. Sun Pharma Global FZE is in the business of manufacturing, marketing, importing and
selling pharmaceutical drug products, including generic drug products. Upon information and
belief, Sun Pharma Global FZE, directly or through its parent, subsidiaries, affiliates and/or
agents, including Sun Ltd., Sun Inc., Sun USA and Caraco, manufactures, markets, imports and
sells generic drugs throughout the United States and in this judicial district. Upon information
and belief, Sun Pharma Global FZE purposefully has conducted and continues to conduct
business, directly or through its parent, subsidiaries, affiliates and/or agents, including Sun Ltd.,
Sun Inc., Sun USA and Caraco, in this judicial district and this judicial district is a likely
destination of Sun Pharma Global FZEs generic products. Sun Pharma Global FZEs authorized
agent in this judicial district is John L. Dauer Jr., Esq., Chief Patent Counsel, Caraco
Pharmaceutical Laboratories, Ltd., 270 Prospect Plains Rd., Cranbury, NJ 08512. Additionally,
Sun Pharma Global FZE has availed itself of the laws of New Jersey by, at least, indicating that
an offer to access confidential information relating to Sun Pharma Global FZEs ANDA No. 78-
614 shall be governed by the laws of the State of New Jersey. Upon information and belief,
Sun Pharma Global FZE has previously submitted to the jurisdiction of this Court and has further
previously availed itself of this Court by asserting counterclaims in other civil actions initiated in
this jurisdiction.
12. Upon information and belief, this Court has jurisdiction over Sun USA. Sun USA
is in the business of manufacturing, marketing, importing and selling pharmaceutical drug
products, including generic drug products. Upon information and belief, Sun USA, directly or
through its parent, subsidiaries, affiliates and/or agents, including Sun Ltd., Sun Inc., Sun
Pharma Global FZE and Caraco, manufactures, markets, imports and sells generic drugs


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throughout the United States and in this judicial district. Upon information and belief, Caracos
website states:
Sun Pharma USA is the US arm of Sun Pharmaceutical Industries, Ltd. (Sun Pharma),
a leading pharmaceutical company in India. Sun Pharma USA consists of Sun Pharma
subsidiaries Caraco Pharmaceutical Laboratories, Ltd. with locations in the Detroit, MI
area, New Jersey and Ohio . . . .
See http://www.caraco.com/aspx/CorporateProfile.aspx (emphasis added) (accessed June 4,
2014).

13. Upon information and belief, this Court has jurisdiction over Caraco. Caraco is in
the business of manufacturing, marketing, importing and selling pharmaceutical drug products,
including generic drug products. Upon information and belief, Caraco, directly or through its
parent, subsidiaries, affiliates and/or agents, including Sun Ltd., Sun Inc., Sun Pharma Global
FZE and Sun USA, manufactures, markets, imports and sells generic drugs throughout the
United States and in this judicial district. Caraco is Sun Pharma Global FZEs authorized agent
in connection with ANDA No. 78-614. Upon information and belief, Caraco has previously
submitted to the jurisdiction of this Court and has further previously availed itself of this Court
by asserting counterclaims in other civil actions initiated in this jurisdiction.
14. Upon information and belief, the Defendants hold themselves out as a unitary
entity for purposes of manufacturing, marketing, selling and distributing generic pharmaceutical
products.
15. Upon information and belief, the Defendants work in concert with each other with
respect to the regulatory approval, manufacturing, marketing, sale and distribution of generic
pharmaceutical products throughout the United States, including in this judicial district.
16. Upon information and belief, venue is proper in this judicial district under
28 U.S.C. 1391(b) and (c), and l400(b).


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FIRST COUNT FOR PATENT INFRINGEMENT
17. The U.S. Patent and Trademark Office (PTO) issued the 615 patent on
September 13, 2011, entitled Low Hygroscopic Aripiprazole Drug Substance and Processes for
the Preparation Thereof. A copy of the 615 patent is attached as Exhibit A.
18. Otsuka is the owner of the 615 patent by virtue of assignment.
19. The 615 patent expires on December 16, 2024 (including pediatric exclusivity).
20. The 615 patent is directed to and claims, inter alia, pharmaceutical solid oral
preparations and processes for preparing pharmaceutical solid oral preparations.
21. Otsuka is the holder of New Drug Application (NDA) No. 21-436 for
aripiprazole tablets, which the FDA approved on November 15, 2002.
22. Otsuka lists the 615 patent in Approved Drug Products with Therapeutic
Equivalence Evaluations (the Orange Book) for NDA No. 21-436.
23. Otsuka markets aripiprazole tablets in the United States under the trademark
Abilify

.
24. Upon information and belief, Sun Pharma Global FZE submitted ANDA No. 78-
614 to the FDA, under Section 505(j), seeking approval to manufacture, use, sell and offer to sell
Sun Pharma Global FZEs generic products in the United States.
25. Otsuka received a letter from Sun Pharma Global FZEs authorized agent, Caraco,
dated May 23, 2014, (Sun Pharma Global FZEs Letter) purporting to include a Notice of
Certification for ANDA No. 78-614 under 21 U.S.C. 355(j)(2)(B)(ii) and 21 C.F.R. 314.95 as
to the 615 patent.
26. Sun Pharma Global FZEs Letter states that the established name of the proposed
drug product that is the subject of the SUN ANDA is Aripiprazole Tablets.


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27. Upon information and belief, Sun Pharma Global FZEs generic products will, if
approved and marketed, infringe at least one claim of the 615 patent.
28. Upon information and belief, under 35 U.S.C. 271(e)(2)(A), Sun Pharma Global
FZE has infringed at least one claim of the 615 patent by submitting, or causing to be submitted
to the FDA, ANDA No. 78-614 seeking approval to manufacture, use, sell and offer to sell Sun
Pharma Global FZEs generic products before the expiration date of the 615 patent.
29. Upon information and belief, Sun Pharma Global FZEs actions relating to
ANDA No. 78-614 complained of herein were done with the cooperation, participation and
assistance, and for the benefit, of the Defendants.
SECOND COUNT FOR PATENT INFRINGEMENT
30. Otsuka realleges, and incorporates in full herein, paragraphs 21, 23, 24 and 26.
31. The PTO issued the 796 patent on November 12, 2013, entitled Low
Hygroscopic Aripiprazole Drug Substance and Processes for the Preparation Thereof. A copy
of the 796 patent is attached as Exhibit B.
32. Otsuka is the owner of the 796 patent by virtue of assignment.
33. The 796 patent expires on March 25, 2023 (including pediatric exclusivity).
34. The 796 patent is directed to and claims, inter alia, aripiprazole crystals.
35. Otsuka lists the 796 patent in the Orange Book for NDA No. 21-436.
36. Sun Pharma Global FZEs Letter purports to include a Notice of Certification for
ANDA No. 78-614 under 21 U.S.C. 355(j)(2)(B)(ii) and 21 C.F.R. 314.95 as to the 796
patent.
37. Upon information and belief, Sun Pharma Global FZEs generic products will, if
approved and marketed, infringe at least one claim of the 796 patent.


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38. Upon information and belief, under 35 U.S.C. 271(e)(2)(A), Sun Pharma Global
FZE has infringed at least one claim of the 796 patent by submitting, or causing to be submitted
to the FDA, ANDA No. 78-614 seeking approval to manufacture, use, sell and offer to sell Sun
Pharma Global FZEs generic products before the expiration date of the 796 patent.
39. Upon information and belief, Sun Pharma Global FZEs actions relating to
ANDA No. 78-614 complained of herein were done with the cooperation, participation and
assistance, and for the benefit, of the Defendants.
THIRD COUNT FOR PATENT INFRINGEMENT
40. Otsuka realleges, and incorporates in full herein, paragraphs 21, 23, 24 and 26.
41. The PTO issued the 760 patent on February 4, 2014, entitled Low Hygroscopic
Aripiprazole Drug Substance and Processes for the Preparation Thereof. A copy of the 760
patent is attached as Exhibit C.
42. Otsuka is the owner of the 760 patent by virtue of assignment.
43. The 760 patent expires on March 25, 2023 (including pediatric exclusivity).
44. The 760 patent is directed to and claims, inter alia, aripiprazole drug substance.
45. Otsuka lists the 760 patent in the Orange Book for NDA No. 21-436.
46. Sun Pharma Global FZEs Letter purports to include a Notice of Certification for
ANDA No. 78-614 under 21 U.S.C. 355(j)(2)(B)(ii) and 21 C.F.R. 314.95 as to the 760
patent.
47. Upon information and belief, Sun Pharma Global FZEs generic products will, if
approved and marketed, infringe at least one claim of the 760 patent.
48. Upon information and belief, under 35 U.S.C. 271(e)(2)(A), Sun Pharma Global
FZE has infringed at least one claim of the 760 patent by submitting, or causing to be submitted


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to the FDA, ANDA No. 78-614 seeking approval to manufacture, use, sell and offer to sell Sun
Pharma Global FZEs generic products before the expiration date of the 760 patent.
49. Upon information and belief, Sun Pharma Global FZEs actions relating to
ANDA No. 78-614 complained of herein were done with the cooperation, participation and
assistance, and for the benefit, of the Defendants.
WHEREFORE, Plaintiff Otsuka respectfully requests that the Court enter judgment in
its favor and against Defendants on the patent infringement claims set forth above and
respectfully requests that this Court:
1) enter judgment that, under 35 U.S.C. 271(e)(2)(A), the Defendants have infringed
at least one claim of the 615 patent through Sun Pharma Global FZEs submission
of ANDA No. 78-614 to the FDA to obtain approval to manufacture, use, sell and
offer to sell Sun Pharma Global FZEs generic products in the United States before
the expiration of the 615 patent;
2) order that the effective date of any approval by the FDA of Sun Pharma Global
FZEs generic products be a date that is not earlier than the expiration of the 615
patent, or such later date as the Court may determine;
3) enjoin the Defendants from the manufacture, use, sale, offer to sell and import of
Sun Pharma Global FZEs generic products until the expiration of the 615 patent,
or such later date as the Court may determine;
4) enjoin the Defendants and all persons acting in concert with the Defendants from
seeking, obtaining or maintaining approval of ANDA No. 78-614 until the
expiration of the 615 patent;


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5) enter judgment that, under 35 U.S.C. 271(e)(2)(A), the Defendants have infringed
at least one claim of the 796 patent through Sun Pharma Global FZEs submission
of ANDA No. 78-614 to the FDA to obtain approval to manufacture, use, sell and
offer to sell Sun Pharma Global FZEs generic products in the United States before
the expiration of the 796 patent;
6) order that the effective date of any approval by the FDA of Sun Pharma Global
FZEs generic products be a date that is not earlier than the expiration of the 796
patent, or such later date as the Court may determine;
7) enjoin the Defendants from the manufacture, use, sale, offer to sell and import of
Sun Pharma Global FZEs generic products until the expiration of the 796 patent,
or such later date as the Court may determine;
8) enjoin the Defendants and all persons acting in concert with the Defendants, from
seeking, obtaining or maintaining approval of ANDA No. 78-614 until the
expiration of the 796 patent;
9) enter judgment that, under 35 U.S.C. 271(e)(2)(A), the Defendants have infringed
at least one claim of the 760 patent through Sun Pharma Global FZEs submission
of ANDA No. 78-614 to the FDA to obtain approval to manufacture, use, sell and
offer to sell Sun Pharma Global FZEs generic products in the United States before
the expiration of the 760 patent;
10) order that the effective date of any approval by the FDA of Sun Pharma Global
FZEs generic products be a date that is not earlier than the expiration of the 760
patent, or such later date as the Court may determine;


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11) enjoin the Defendants from the manufacture, use, sale, offer to sell and import of
Sun Pharma Global FZEs generic products until the expiration of the 760 patent,
or such later date as the Court may determine;
12) enjoin the Defendants and all persons acting in concert with the Defendants, from
seeking, obtaining or maintaining approval of ANDA No. 78-614 until the
expiration of the 760 patent;
13) declare this to be an exceptional case under 35 U.S.C. 285 and 271(e)(4) and
award Otsuka costs, expenses and disbursements in this action, including
reasonable attorney fees; and
14) award Otsuka such further and additional relief as this Court deems just and proper.
Respectfully submitted,

s/John F. Brenner
John F. Brenner
Melissa A. Chuderewicz
brennerj@pepperlaw.com
chuderem@pepperlaw.com
PEPPER HAMILTON LLP
Suite 400
301 Carnegie Center
Princeton, New Jersey 08543
(609) 452-0808
Attorneys for Plaintiff
Otsuka Pharmaceutical Co., Ltd.
Dated: July 7, 2014
Of counsel:
James B. Monroe
Paul W. Browning
Denise Main
FINNEGAN, HENDERSON,
FARABOW, GARRETT & DUNNER, LLP
901 New York Avenue, N.W.
Washington, DC 20001-4413
(202) 408-4000